JPAC Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee

Screening - automated

Quality Audit Preparation

Process:

Automated grouping and antibody screening

Area:

Blood Bank

Issue fridge

Auditees:

Any person involved in the process this may include:

  • Blood Bank staff BMS or MLA
  • On Call staff

Initial preparation:

Is SOP for the process:

  • Specific
  • In date
  • Appropriately signed/authorised by an authorised signatory
  • Complete equipment list
  • Complete reagent list
  • Official copy
  • Links to COSHH / Risk assessments
  • Regularly reviewed

Additional Evidence required:

  1. Validation of automated equipment
  2. Validation of interface
  3. Validation of reagents
  4. Training records and competency assessments/competency of trainers
  5. Maintenance schedule
  6. Maintenance visits, planned and unplanned and sign off post visit
  7. Evidence of controls and these are working
  8. Evidence of External QC
  9. Document control
  10. Electrical equipment testing
  11. Disposal of waste/ log of disposal
  12. Cleaning schedule
  13. Reagent log

Interviews/process:

  1. Observation
  2. Questions
  3. Knowledge assessment – this should cover
    • Check for ID samples numbers and linked to request form
    • Rules for editing results
    • Validation of samples
    • Validation of results
    • When to run controls
    • Failure of controls
    • Discrepancies from historical group
  4. Objective evidence
  5. Reagents
    • Expiry dates
    • CE marked
    • Inserts
    • Storage
  6. Records
    • Storage
    • Maintenance
  7. Reports

Additional requirements:

  1. General housekeeping of the area
  2. Trouble shooting plans
  3. Storage issues for reagents (temperature)/waste